inforMED
MalfunctionFAM

PENTAX

Received May 29, 2023 · Event occurred May 11, 2023

Report 9610877-2023-54705 · MDR key 17017584

Device

Generic name

Video Sigmoidoscope 4.2c 12.8t 700l Fwj

Model number

ES-3870K

Product problems

  • Break
  • Break

Patient

Unknown

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Additional Manufacturer Narrative

THE PRODUCT WAS RETURNED TO PENTAX MEDICAL FOR REPAIR. OUR TECHNICIAN CHECKED THE RETURNED UNIT AND CONFIRMED, THAT THE CCD MODULE WITH DRIVE PCB AS DEFECTIVE. BASED ON THE RESULT, WE CONCLUDED THAT IT WAS CAUSED, DUE TO THE EXCESSIVE FORCE APPLIED ON THE CCD MODULE WITH DRIVE PCB. IN ADDITION, OUR TECHNICIAN CONFIRMED, THAT THE AIR NOZZLE CLOGGED, AND THE CCD MODULE WITH DRIVE PCB DISTORTED IMAGE. HOWEVER, THESE DEFECTS ARE NOT THE MAIN CAUSE, AND/OR IRRELEVANT TO THE ALLEGED COMPLAINT. BASED ON THE TECHNICAL REPORT "HR-RPT-0586(IMAGE FAILURE)" AND/OR THE RISK ANALYSIS RESULTS, IT WAS EVALUATED TO SUBMIT MDR.

Description of Event or Problem

THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. VIDEO IMAGE FAILURE.